JT001 – COMPUTER SYSTEM VALIDATION

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

Develop and execute validation protocols for computer systems, including software, hardware, and applications.

Collaborate with multidisciplinary teams to define requirements and ensure that systems comply with FDA regulations, GxP, and other applicable standards.

Document and manage validation evidence, ensuring the integrity and availability of records.

Conduct risk analyses and impact assessments for new and existing systems.

Provide training and support to users regarding validation documentation and system usage.

Stay updated on trends and regulations in computer system validation.

Qualifications:

Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.

Previous experience in computer system validation within the pharmaceutical or biotechnology industry.

In-depth knowledge of GxP and FDA regulations.

Strong technical documentation and project management skills.

Excellent communication and teamwork abilities.

Problem-solving skills and informed decision-making capability.

5-8 years of experience in CSV

Experience in pharmaceuticals, medical devices or biopharma

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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